Diabetes Mellitus, Type 1Phase 1NCT07087795

A Study to See the Effect of NNC0194-0499 Alone or in Combination With Semaglutide on Blood Sugar Control in People Living With Type 1 Diabetes

A Phase 1 study testing NNC0194-0499 and Semaglutide in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study is testing the effect of a new study medicine NNC0194-0499 in type 1 diabetes. The purpose of the study is to compare the effect of NNC0194-0499 on the blood sugar levels of participants with type 1 diabetes when taken in combination with semaglutide or placebo. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: NNC0194-0499 and Semaglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteGermany
Study dates: 1 Jul 2025to 25 Sep 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female.
Age 18-64 years (both inclusive) at the time of signing the informed consent.
Body mass index 22-35 kilogram per square meter (kg/m^2) (both inclusive) for Part A and 27-35(kg/m^2) (both inclusive) for Part B at the day of screening.
Diagnosed with type 1 diabetes mellitus greater than equal to (≥) 1 year prior to the day of screening.
Treated with multiple daily insulin injections and stable insulin dose greater than (>) 90 days prior to the day of screening, as judged by the investigator.
Use of Continuous glucose monitoring (CGM) device > 180 consecutive days prior to the day of screening.

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Glycated haemoglobin (HbA1c) from 7.2 - 9.0% (both inclusive).
Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Ability and willingness to wear the Novo Nordisk provided CGM device according to the protocol including replacement of CGM sensor at home.
Ability and willingness to refrain from wearing own CGM/Flash glucose monitor for the duration of the study, as judged by the investigator.

Who cannot join

Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Treatment with glucagon-like peptide-1(GLP-1) RA within 90 days before screening.
Use of any medication with unknown or unspecified content within 90 days before screening.
Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.
Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity).
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within 180 days prior to the day of screening.
Any episode of diabetic ketoacidosis within 90 days before screening.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460

Other trials in Germany

About this study

Official title: A Study to Investigate Efficacy and Safety of NNC0194-0499 Versus Placebo, Both Administered Alone or in Combination With Semaglutide in People With Type 1 Diabetes

Conditions: Diabetes Mellitus, Type 1
Being tested: NNC0194-0499, Placebo, Semaglutide
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NNC0194-0499Drug
Participants will receive subcutaneous NNC0194-0499 once weekly.
PlaceboDrug
Participants will receive placebo matched to NNC0194-0499 subcutaneously.
SemaglutideDrug
Participants will receive subcutaneous semaglutide once weekly.

Study groups in NCT07087795
Study group	Role	What they receive
Part A: NNC0194-0499/Placebo	Experimental	After a 2-week run-in period; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo. Between the two treatment periods; there is a wash-out period. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo. Receives: Drug: NNC0194-0499; Drug: Placebo
Part B: NNC0194-0499/Placebo + Semaglutide	Experimental	After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide. Receives: Drug: NNC0194-0499; Drug: Placebo; Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
Percentage point (%-points).
Measured: From baseline (day -14 - -1) to day 36-49 / day 106-119
Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
%-points.
Measured: From baseline (day -14 - -1) to day 92-105 / day 162-175

Secondary outcomes (11)

Change in coefficient of variation (CV) of sensor glucose, total
%-points.
Measured: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
Change in mean sensor glucose (SG)
Millimoles per liter (mmol/L).
Measured: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)
%-points.
Measured: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
Change in time above range (TAR) >13.9 mmol/L (>250 mg/dL)
%-points.
Measured: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
Time below range (TBR) <3.9 mmol/L (70 mg/dL)
% of time.
Measured: Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175
Time below range (TBR)<3.0 mmol/L (54 mg/dL)
% of time.
Measured: Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175
Change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL)
%-points.
Measured: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
Change in mean total daily insulin dose per kg
Ratio to baseline.
Measured: Part A: From baseline (day -3 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -3 - -1) to day 92-105 / day 162-175
Change in triglycerides
Ratio to baseline.
Measured: Part A: From baseline (day 1) to day 50/ day 120; Part B: From baseline (day 1) to day 106/ day 176
Number of adverse events (AEs)
Number of events.
Measured: Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211
Number of severe hypoglycaemic episodes (level 3)
Number of episodes.
Measured: Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202525 Sep 2026

First posted28 Jul 2025
Study start1 Jul 2025
Primary completion12 Sep 2026 (estimated)
Study completion25 Sep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 96 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07087795
Sponsor's protocol ID: NN6497-8316
Other IDs: U1111-1315-5122, 2024-519533-38
Status last verified: Aug 2026
First submitted: 29 Jun 2025
Last updated: 13 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Investigate Efficacy and Safety of NNC0194-0499 Versus Placebo, Both Administered Alone or in Combination With Semaglutide in People With Type 1 Diabetes
ClinicalTrials.gov ID: NCT07087795
Acronym / sponsor ID: NN6497-8316
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 96 participants (estimated)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 1 Jul 2025 (actual)
Primary completion: 12 Sep 2026 (estimated)
Study completion: 25 Sep 2026 (estimated)
First posted: 28 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Part A: NNC0194-0499/Placebo	Experimental	Drug: NNC0194-0499, Drug: PlaceboAfter a 2-week run-in period; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo. Between the two treatment periods; there is a wash-out period. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo.
Part B: NNC0194-0499/Placebo + Semaglutide	Experimental	Drug: NNC0194-0499, Drug: Placebo, Drug: SemaglutideAfter the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Male or female.
Age 18-64 years (both inclusive) at the time of signing the informed consent.
Body mass index 22-35 kilogram per square meter (kg/m^2) (both inclusive) for Part A and 27-35(kg/m^2) (both inclusive) for Part B at the day of screening.
Diagnosed with type 1 diabetes mellitus greater than equal to (≥) 1 year prior to the day of screening.
Treated with multiple daily insulin injections and stable insulin dose greater than (>) 90 days prior to the day of screening, as judged by the investigator.

Key exclusion criteria (7 listed)

Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Treatment with glucagon-like peptide-1(GLP-1) RA within 90 days before screening.
Use of any medication with unknown or unspecified content within 90 days before screening.
Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.
Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NNC0194-0499Participants will receive subcutaneous NNC0194-0499 once weekly.	Drug	Part A: NNC0194-0499/Placebo, Part B: NNC0194-0499/Placebo + Semaglutide
PlaceboParticipants will receive placebo matched to NNC0194-0499 subcutaneously.	Drug	Part A: NNC0194-0499/Placebo, Part B: NNC0194-0499/Placebo + Semaglutide
SemaglutideParticipants will receive subcutaneous semaglutide once weekly.	Drug	Part B: NNC0194-0499/Placebo + Semaglutide

Primary outcome

Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
Time frame: From baseline (day -14 - -1) to day 36-49 / day 106-119
Percentage point (%-points).
Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
Time frame: From baseline (day -14 - -1) to day 92-105 / day 162-175
%-points.

11 secondary outcomes

Change in coefficient of variation (CV) of sensor glucose, total
Time frame: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
Change in mean sensor glucose (SG)
Time frame: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)
Time frame: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
Change in time above range (TAR) >13.9 mmol/L (>250 mg/dL)
Time frame: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
Time below range (TBR) <3.9 mmol/L (70 mg/dL)
Time frame: Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175
Time below range (TBR)<3.0 mmol/L (54 mg/dL)
Time frame: Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175
Change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL)
Time frame: Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175
Change in mean total daily insulin dose per kg
Time frame: Part A: From baseline (day -3 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -3 - -1) to day 92-105 / day 162-175
Change in triglycerides
Time frame: Part A: From baseline (day 1) to day 50/ day 120; Part B: From baseline (day 1) to day 106/ day 176
Number of adverse events (AEs)
Time frame: Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211
Number of severe hypoglycaemic episodes (level 3)
Time frame: Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Transparency (dept. 2834) study director

Novo Nordisk A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0194-0499 and Semaglutide in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL) (time frame: From baseline (day -14 - -1) to day 36-49 / day 106-119). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07087795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.